GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall of medical imaging software with measurement accuracy defect. No reported illnesses or injuries. This represents a risk-of-harm product where injury has not yet been reported, per rubric severity score 3 (High).
Plain-English summary
GE Healthcare has recalled three versions of medical imaging software: Centricity Universal Viewer 6.0 (Model 2088026-9XX), Centricity Universal Viewer 7.0 (Model 5826659-0XX), and Universal Viewer 8.0 (Model 5865740-00x). These diagnostic image-viewing applications are used in healthcare settings to display and analyze medical images.
The recalled software versions may produce inaccurate distance and area measurements when the Global Stack viewport feature is used. This measurement inaccuracy could affect the reliability of diagnostic measurements and clinical decision-making by healthcare providers.
Approximately 1,690 devices have been distributed. Distribution includes healthcare facilities throughout the United States and in more than 40 countries worldwide, including Argentina, Australia, Canada, Japan, Mexico, and the United Kingdom, among others.
The recalled product
- Product
- (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 1,690
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- (1) Centricity Universal Viewer 6.0 - UDI 00840682103800
- Software versions 6.0 SP9
- 6.0 SP9.0.1 through 6.0 SP9.0.1.11
- 6.0 SP9.0.2
- 00840682145558
- Software versions 7.0 through 7.0 SP0.0.4.9
- 7.0 SP0.0.5
- 7.0 SP0.1.0
- and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610
- Software versions 8.0
- 8.0 SP0.1.0
- and 8.0 SP0.1.1.
Distribution
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